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Translation of Biomarkers into Clinical Practice

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Molecular Pathology of Breast Cancer

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Abstract

The practice of precision medicine requires reliable and informative biomarkers to guide clinical management decisions. Tests based on biomarkers may be used for a variety of purposes, including to inform prognosis, select therapy, and monitor for disease recurrence or progression. Biomarker-based tests are already widely used for clinical management of breast cancer, for example the use of hormone receptors for guiding use of endocrine therapies, HER2 status for selection of HER2-targeting agents, and gene expression signatures for prognosis and decisions about use of adjuvant chemotherapy. In order to translate a biological finding to a clinical-grade biomarker test for use in patient care decisions, one must begin with consideration of what decision the biomarker test will inform and in what patient population and clinical setting it will be used in order to determine what evidence must be accumulated to support the proposed use. Essential steps in the evidentiary process include establishing analytical validity of the biomarker measurement process, demonstrating clinical validity of the biomarker by establishing its association with a clinical endpoint of interest, and showing that the biomarker test has clinical utility in the sense that its clinical use leads to a favor benefit-to-risk balance for the patient. Through a series of examples, evidence requirements and interpretation are illustrated. Adherence to the principles set forth here should aid in making the clinical translation of biomarkers more efficient and lead to wider availability of biomarker-based tests that perform reliably and can be used with confidence to inform clinical management decisions that lead to better outcomes for patients with breast cancer.

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Author information

Authors and Affiliations

  1. Division of Cancer Treatment and Diagnosis, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD, 20892, USA

    Lisa Meier McShane, Tracy G. Lively & Hala R. Makhlouf

  2. Department of Pathology, Faculty of Medicine, Ain Shams University, 38 Al Abbassia, Greater Cairo, Cairo, 11566, Egypt

    Hala R. Makhlouf

Authors
  1. Lisa Meier McShane
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  2. Tracy G. Lively
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  3. Hala R. Makhlouf
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Corresponding author

Correspondence to Lisa Meier McShane .

Editor information

Editors and Affiliations

  1. Pathology & Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA

    Sunil Badve

  2. Indiana University School of Medicine, Dept of Pathology & Laboratory Medicine Indiana University School of Medicine, Indianapolis, Indiana, USA

    Yesim Gökmen-Polar

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McShane, L.M., Lively, T.G., Makhlouf, H.R. (2016). Translation of Biomarkers into Clinical Practice. In: Badve, S., Gökmen-Polar, Y. (eds) Molecular Pathology of Breast Cancer. Springer, Cham. https://doi.org/10.1007/978-3-319-41761-5_1

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